Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?

NCT ID: NCT06057090

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-13

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients.

The main questions it aims to answer are:

* Does the presence of a certified therapy dog during dental procedure requiring an injection reduce anxiety and improve behavior in pediatric dental patients?
* How do the parents of pediatric dental patients who participate in the study view the use of a certified therapy dog in their child's treatment?
* Does the presence of a certified therapy dog result in different concentrations of microbes in the treatment room?

All participants will receive standard of care. Researchers will compare the group with a therapy dog present to a group who does not have a therapy dog present to see if heart rate, oxygen saturation, percentage of nitrous oxide administered, and Frankl scores differ between the groups.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Therapy Animals Dental Anxiety Child Behavior Anesthesia, Local

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Therapy Dog

This group will have a certified therapy dog present in the treatment room throughout the procedure. Prior to the procedure, the participant will be briefly introduced to the therapy dog and handler, who will remain in the room until the end of the procedure.

Group Type EXPERIMENTAL

Therapy Dog

Intervention Type BEHAVIORAL

Certified, volunteer therapy dogs and their handlers will be present in the room during procedures in the experimental arm to see if their presence reduces anxiety and improves behavior in pediatric dental patients.

Control

The control group receives standard of care and does not have a therapy dog present in the room during their treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Therapy Dog

Certified, volunteer therapy dogs and their handlers will be present in the room during procedures in the experimental arm to see if their presence reduces anxiety and improves behavior in pediatric dental patients.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 3-7
* Children who are patients at the Medical University of South Carolina Department of Pediatric Dentistry
* Children classified as category 1 or 2 according to the American Society of Anesthesiologists Physical Status Classification
* Children whose parents/guardians are willing to consent to the child participating in the study
* Availability of parent to be present during treatment
* Children who require further care that includes the injection of a local anesthetic and whose procedure will take less than one hour

Exclusion Criteria

* Patients whose cases are considered emergencies
* Patients who are classified as category 3 or higher according to the American Society of Anesthesiologists Physical Status Classification (6)
* If patient's medical status has worsened since initial evaluation
* Known allergy to dogs or other animals
* Past history of dental trauma
* Past history of animal bites or traumatic experience with a dog
* Emotional or developmental delays
* If, on the day of the treatment, patient presents with fever or other illness
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julie L Marshall, PhD

Role: PRINCIPAL_INVESTIGATOR

James B. Edwards College of Dental Medicine, Medical University of South Carolina

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of South Carolina Pediatric Dental Clinic

Charleston, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Paryab M, Arab Z. The effect of Filmed modeling on the anxious and cooperative behavior of 4-6 years old children during dental treatment: A randomized clinical trial study. Dent Res J (Isfahan). 2014 Jul;11(4):502-7. doi: 10.4103/1735-3327.139426.

Reference Type BACKGROUND
PMID: 25225565 (View on PubMed)

Vincent A, Easton S, Sterman J, Farkas K, Heima M. Acceptability and Demand of Therapy Dog Support Among Oral Health Care Providers and Caregivers of Pediatric Patients. Pediatr Dent. 2020 Jan 15;42(1):16-21.

Reference Type BACKGROUND
PMID: 32075705 (View on PubMed)

Kamioka H, Okada S, Tsutani K, Park H, Okuizumi H, Handa S, Oshio T, Park SJ, Kitayuguchi J, Abe T, Honda T, Mutoh Y. Effectiveness of animal-assisted therapy: A systematic review of randomized controlled trials. Complement Ther Med. 2014 Apr;22(2):371-90. doi: 10.1016/j.ctim.2013.12.016. Epub 2014 Jan 6.

Reference Type BACKGROUND
PMID: 24731910 (View on PubMed)

Casamassimo PS, Seale NS, Rutkauskas Ii JS, Rutkauskas JS. Are U.S. Dentists Adequately Trained to Care for Children? Pediatr Dent. 2018 Mar 15;40(2):93-97.

Reference Type BACKGROUND
PMID: 29663907 (View on PubMed)

Stern J, Agarwal A, Pozun A. Pediatric Procedural Sedation. 2025 Mar 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572100/

Reference Type BACKGROUND
PMID: 34283466 (View on PubMed)

Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

Reference Type BACKGROUND
PMID: 20332509 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00129098

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.